NIH Employees Object to New Ethics Rules

Ricardo Alonso-ZaldivarTimes Staff Writer

A strict new conflict-of-interest policy at the National Institutes of Health has provoked renewed protest from staff scientists at the nation's premier institution for medical research, but a top official said Wednesday it was unlikely that the rules would be significantly changed as a result.

The new rules, announced this month by NIH Director Elias A. Zerhouni, "substantially overreach and will severely and irreparably compromise the NIH's mission," a group of employees declared in an agency newsletter that was to be distributed today.

"These new regulations will discourage talented, innovative scientists from staying at or being recruited to the NIH, and preclude scientists already at the NIH from participating as full members of the scientific community," the employees wrote.

In the same issue of the newsletter, Zerhouni defended the new rules, which were to become final after a 60-day comment period in early April.

The policy bans scientists from accepting consulting fees or any other compensation from the biomedical industry. It also bars about 7,000 senior employees from owning stock in many types of medical companies, and limits such holdings to $15,000 for all other employees.

"I have taken a strong position to protect the credibility of NIH science," Zerhouni said.

"You must not serve two masters," he wrote. "You cannot have another financial interest in the work that you do for NIH outside of your federal job.

"You must not double dip," he added. "If the taxpayers have paid for your work, someone else may not pay you again for that work."

Within those limits, he asserted, scientists would remain free to speak, write and interact with peers in academia and industry.

A delegation of NIH researchers is scheduled to meet with Zerhouni today to voice complaints about the ethics policy. However, NIH Deputy Director Raynard S. Kington said in an interview that a significant easing of the policy for senior researchers was unlikely.

"I cannot anticipate under any circumstances changing large sections of the rule for the most senior people, who have the greatest potential -- because of their authority -- for conflicts of interest," Kington said.

Many of the agency's top professionals seem to find the broad prohibition on stock ownership particularly objectionable.

The statement by the dissenting scientists said that "such expansive restrictions seem unnecessary and unlinked to preventing conflicts of interest, but they will have profoundly detrimental financial impacts on individual employees and hinder recruitment and retention."

The statement was signed by 18 NIH employees, who represent others. Many of the scientists had urged Zerhouni last year not to enact sweeping restrictions; some of them protested during a meeting with the director three weeks ago.

In his interview with The Times, Kington also said that an internal review had found that the number of NIH scientists who had accepted drug-company consulting fees without getting required, advance permission was not as high as had been speculated at a congressional hearing in June. Citing clerical-type errors or confusion within the NIH, Kington said that about half of the 100 employees suspected of having collected industry compensation without permission were found to have acted in compliance with agency rules.

The internal review started in mid-2004, after the House Energy and Commerce Committee surveyed 20 biomedical companies and found scores of paid arrangements with NIH employees that the agency had not acknowledged. The number of NIH employees who accepted compensation from the companies without the required approval remains unconfirmed, in part because the congressional committee contacted only 20 companies.

NIH officials are evaluating whether to refer the conduct of various agency scientists for criminal investigation, Kington said.

He said the agency's conflict-of-interest problems were broad. In addition to failing to report outside involvements, some scientists accepted consulting deals with companies involved in NIH research, and some were featured on company Internet sites in a way that appeared to promote the firm or its products.

Other NIH scientists advised federal panels or helped draft policy recommendations affecting the products sold by their company clients, at times without publicly acknowledging their paid arrangements with the companies.

Zerhouni has noted that various NIH decisions and announcements have the potential to affect company stock prices.

Kington and Zerhouni have made it clear that the new, tighter policy prohibiting drug-company consulting fees was based on a conclusion that the agency had broad and serious ethics shortcomings. Indeed, a report by the U.S. Office of Government Ethics concluded in August that the NIH was beset with a "permissive culture on matters relating to outside compensation" and that tighter restrictions were needed.

"We never said we were going to base our policy on the list of names that Congress obtained," Kington said. "We concluded that our system of oversight was not up to the task of monitoring a wide range of complicated outside activity, and we wanted to start over with a clean slate. The preponderance of all the evidence gave us pause."